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InSite Vision receives Canadian regulatory approval for AzaSite
ALAMEDA, Calif. — Health Canada's Therapeutic Products Directorate has approved InSite Vision's new drug submission for AzaSite for treating bacterial conjunctivitis in patients older than 1 year of age, the company announced.
Canadian regulatory approval was based on positive results from two pivotal phase 3 safety and efficacy trials of AzaSite (azithromycin 1%) that enrolled more than 1,400 patients with bacterial conjunctivitis in the U.S. and Latin America. These patients received AzaSite twice daily for 2 days and once daily for 3 days thereafter.
In both trials, AzaSite clinically and statistically significantly improved the clinical resolution of symptoms and bacterial eradication compared with placebo. In addition, AzaSite was found to be equivalent to tobramycin administered four times daily for 5 days in clinical resolution and bacterial eradication, according to an InSite press release.
AzaSite was approved for treating bacterial conjunctivitis by the U.S. Food and Drug Administration in April 2007 and was launched for sale in August 2007 by Inspire Pharmaceuticals, owner of an exclusive license to market AzaSite in the U.S. and Canada. Under the terms of the companies' agreement, the new drug submission will transfer to Inspire Pharmaceuticals, and Inspire will be responsible for marketing AzaSite in Canada.